From the ideation of the scientific question, sponsors can consider integrating ePRO tools in protocol designs. Decentralized and hybrid clinical trials can widen the data points and make the most of each trial. Here we share five steps to introduce an ePRO into a protocol: Define the objectives an ePRO tool can address: Identify the… Continue reading How to include an ePRO in your protocol design
Electronic Clinical Outcome Assessments (eCOA) and Electronic Patient Reported Outcomes (ePRO) are two types of electronic data collection methods. While they may seem similar, there are some differences between them that are important to acknowledge. ePRO involves patients reporting their own health outcomes directly to their healthcare provider or research team. This is usually… Continue reading Differences and similarities between an eCOA and ePRO
An FDA 2020 report (1) has shown a 28% decrease in underrepresented populations in United States clinical trials compared to 2018. Moreover, the 2022 FDA guidance for the industry to improve underrepresented racial and ethnic participants’ enrollment is a call to action to get clinical data that really reflects the diversity of the population expected… Continue reading Rising Equity in Clinical Trials and Emerging Countries Through Tech
ePRO/eCOA Capabilities to better conduct Clinical Studies ePRO/eCOA tools have revolutionized the clinical research industry. The first concept was raised a decade ago, but the idea of integrations between systems or interoperability was far from easy. In the past three years, the industry has experienced a boom of new technology development, broadening the data source… Continue reading Seven ePRO/eCOA Capabilities to Better Conduct Clinical Studies in Latin America
An efficient clinical trial of the polio vaccine was critical for the emergency approval of the sponsor vaccine against the second wild strain. Then, solve the delicate health situation in Africa due to the high number of children infected with a variant that was thought to have been eliminated, but that increased again after the… Continue reading Efficient Clinical Trial of the Polio Vaccine Against the Second Wild Strain, Vital for Children in Africa
Cevaxin, a research Site located in Panama, used TrialPal to achieve an outstanding eDiary reporting compliance rate in a Phase I vaccine clinical trial with older adults. While developing clinical trials, research sites usually face common challenges, such as technology adoption regarding participant reporting and timely monitoring. Understanding this and the particularities of the vaccine… Continue reading How to achieve a 98% eDiary reporting compliance rate in older adults with TrialPal
COVID-19 studies in healthcare workers in University of Mainz Integra IT had the opportunity to participate and contribute with its tools in observational COVID-19 studies conducted by the University of Mainz on COVID-19 and its impact on healthcare workers. It was the first project of developed Integra IT in Germany. The project collected data on… Continue reading COVID-19 studies in healthcare workers – University of Mainz
Integra IT software solutions has been essential for developing the Fiocruz vaccine Phase 3 trial for SARS-CoV-2 in Brazil, achieving efficiency in data collection and organization. This project collected information from 10,000 volunteers for a year, managing their data via Integra IT’s TrialPal and PFS tools. The project was carried out in Brazil, a… Continue reading Integra IT, part of the Fiocruz COVID-19 vaccine trial in Brazil
Peru, a country of nearly 33 million people, was hit by the COVID-19 coronavirus pandemic mainly because the health system, like that of many other countries, was not prepared for a health challenge of such a magnitude. According to official figures, there were only 100 intensive care unit beds and 300 hospital beds in the… Continue reading Integra IT, COVID19 Study in Peru
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